Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)

• Sponsor: Yonsei University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02373462
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease With Intermittent Claudication	Drug: Olmesartan; Drug: other anti-hypertensive drug	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Aug 25, 2015
• Actual Primary Completion Date: Nov 17, 2015
• Actual Study Completion Date: Nov 17, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: olmesartan group olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg)	Drug: Olmesartan
Active Comparator: other group other anti-hypertensive drug (titrating BP <140/90 mmHg)	Drug: other anti-hypertensive drug; CCB, diuretics, alpha blocker, direct vasodilator, beta blocker

Outcome Measures

Primary Outcome Measures

1. Pain free maximum walking distance and time [12th week]

   Effect of olmesartan in maximum, pain free walking distance & time

Secondary Outcome Measures

1. Quality of life as measured by questionnaires [24th week]

   Effect of olmesartan in quality of life (WIQ, SF-36)

Other Outcome Measures

1. Pulse wave analysis as measured by PWV [24th week]

   pulse wave velocity

2. Blood pressure by measured by 24hr ABPM [24th week]

   24hr ambulatory blood pressure monitoring

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged between 20 and 85 years at visit 1

• Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months

• Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed)

• Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment

Exclusion Criteria:

• Blood pressure of more than 180/110 mmHg

• Patients taking ARBs or ACE inhibitors treatment for at least 6 months before

• Patients taking aldosterone receptor antagonists at least 6 months before

• Patients with serum creatinine of more than 3 mg/dL

• serum potassium (K+) > 5.5mg/dl

• History of bilateral renal artery stenosis

• History of acute coronary syndrome or heart failure hospitalization within 6 months

• Peripheral arterial revascularization planned within 1 month

• Critical limb ischemia

• Patients with impaired cognition (e.g. dementia)

• pregnancy or women at age of childbearing potential

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Department of Internal Medicine, Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02373462
• Other Study ID Numbers: 4-2014-0888
• First Posted: Feb 27, 2015
• Last Update Posted: Jan 28, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Peripheral Arterial Disease; Intermittent Claudication; Olmesartan; Antihypertensive Agents

Study Results

No Results Posted as of Jan 28, 2019